Efficacy and safety of herbal formulation rich in standardized fenugreek seed extract as add-on supplementation in patients with type 2 diabetes mellitus on sulfonylurea therapy: A 12-week, randomized, double-blind, placebo-controlled, multi-center study
Amit D Kandhare1, Nadeem Rais2, Nivedita Moulick3, Alaka Deshpande4, Prasad Thakurdesai1, Sunil Bhaskaran1
1 Department of Scientific Affairs, Indus Biotech Private Limited, Pune, Maharashtra, India
2 Endocrine and Metabolic Section, Chowpatty Medical Centre, Babulnath Road, Mumbai, Maharashtra, India
3 Department of Medicine, Lokmanya Tilak Memorial Medical College and Lokmanya Tilak General Hospital, Sion, Mumbai, Maharashtra, India
4 Department of Medicine, Grant Medical College and Sir JJ Group of Hospitals, Byculla, Mumbai, Maharashtra, India
Amit D Kandhare
Department of Scientific Affairs, Indus Biotech Private Limited, 1, Rahul Residency, Off Salunke Vihar Road, Kondhwa, Pune - 411 048, Maharashtra
Source of Support: None, Conflict of Interest: None
Background: Type 2 diabetes mellitus (T2DM) is a chronic, complex, and progressive illness that often needs combination therapy for better glycemic control. IDM1, an herbal formulation which is rich in standardized fenugreek seed extract. Aim: The aim of this study is to evaluate the efficacy and safety of add-on therapy of IDM1 in T2DM patients inadequately controlled on sulfonylurea monotherapy. Materials and Methods: In this 12-week, randomized, double-blind, placebo-controlled, multi-centric study, T2DM patients which inadequate glycemic control with background stable dose medication of sulfonylurea was screened (n = 120). The patients were randomized 1:1 to add-on therapy of IDM1 and placebo, 700 mg three times daily for 12 weeks. Results: A total of 119 patients were randomized and included in the efficacy analysis (IDM1, n = 60; placebo, n = 59). At week 12, adjusted fasting plasma glucose (FPG) (20 mg%), postprandial plasma glucose (PPPG) (26 mg%), and glycated hemoglobin (HbA1c) (0.9 mg%) was reduced significantly (P < 0.05) from baseline as compared to placebo group (FPG: 7 mg%; PPPG: 4 mg% and HbA1c: 0.4 mg%). These beneficial effects were seen as early as 1 month after consumption of IDM1 and continued until at least 15 days after withdrawal of IDM1. Hypoglycemic events were mostly mild, and none required emergency treatment. There were no major changes in body weight, hematology, and biochemistry at week 12 as compared to baseline. Overall AEs rates were similar in both groups. Conclusions: IDM1 is a safe, effective, and well-tolerated add-on oral medication therapy that supports healthy blood sugar levels and glycosylated hemoglobin levels in T2DM patients inadequately controlled with a sulfonylurea.
Abbreviation used: AEs: Adverse events; ALP: Alkaline phosphatase; ALT: Alanine transaminase; AST: Aspartate transaminase; BMI: Body mass index; BUN: Blood urea nitrogen; FPG: Fasting plasma glucose; GGT: Gamma glutamyl transferase; HbA1c: Glycated hemoglobin; HDL: High-density lipoproteins; LDH: Lactate dehydrogenase; LDL: Low-density lipoproteins.